Evaluation of intravaginal electrical stimulation parameters in women with pelvic organ prolapse.

Not Applicable

Completed

• Conditions: Pelvic organ prolapse; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12623000631606
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-08
• Study Completion: 2024-01-24
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

The women in the following group:
1.Women 18 years of age or above
2.Women with Pelvic Organ Prolapse Quantification System (POP–Q) Stage 2 or 3
3.Women with a ring pessary due for checking or replacement
The following criteria are relevant as the women most likely to benefit from the solution are those with these grades of prolapse, and the demographics most likely to suffer from POP are women above 50 years of age or post-partum women

Exclusion Criteria

1.Women below 18 years of age
2.Patients with an intellectual impairment
3.Women with an allergy to nickel or stainless steel.
4.People in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process
5.People highly dependent on medical care
6.Women with a pre-existing cardiac condition and/or possess a cardiac pacemaker or neuromodulation device
7.Women with an active implantable medical device
8.Women with an active deep vein thrombosis
9.Women who are pregnant or within a period of 3 months post-partum
10.Women with any known or suspected tissue damage (eg. levator avulsion) or malignancy, active infection/disease in the vaginal region, impaired vaginal sensation, recently radiated tissue, or recent history of gynaecological surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Strength of pelvic floor muscle contraction determined using the digital palpation scale developed by the International Continence Society (Absent vs Weak vs Normal/moderate vs Strong contraction) and transperineal ultrasound. [ Assessed continuously during stimulation at each probe insertion depth]

Secondary Outcome Measures

Name	Time	Method
Stimulation frequency determined by accessing device settings [ Assessed continuously during stimulation ]; Pain/discomfort perceived by participants using 11-point visual analog scale [ Immediately post-stimulation ]; Side effects experienced by participants using a study-specific questionnaire. Examples include pain, irritation, discomfort, and bleeding. [ Immediately post-stimulation ]; Patient feedback on device experience and overall acceptability using a study-specific questionnaire [ Immediately post-stimulation ]